EXTRANEAL (icodextrin) Peritoneal Dialysis Solution - Baxter

Directions for Use
For complete CAPD and APD system preparation, see directions accompanying
ancillary equipment.
Aseptic technique should be used.
Warming
For patient comfort, EXTRANEAL can be warmed to 37°C (98°F). Only dry heat
should be used. It is best to warm solutions within the overwrap using a heating
pad. Do not immerse EXTRANEAL in water for warming. Do not use a microwave
oven to warm EXTRANEAL. Heating above 40°C (104°F) may be detrimental to
the solution.
To Open
To open, tear the overwrap down at the slit and remove the solution container.
Some opacity of the plastic, due to moisture absorption during the sterilization
process, may be observed. This does not affect the solution quality or safety and
may often leave a slight amount of moisture within the overwrap.
Inspect for Container Integrity
Inspect the container for signs of leakage and check for minute leaks by
squeezing the container firmly.
Adding Medications
Some drug additives may be incompatible with EXTRANEAL.
See DOSAGE AND ADMINISTRATION section for additional information. If the
re-sealable rubber plug on the medication port is missing or partly removed, do
not use the product if medication is to be added.
1. Put on mask. Clean and/or disinfect hands.
2. Prepare medication port site using aseptic technique.
3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the
medication port and inject additive.
4. Reposition container with container ports up and evacuate medication port by
squeezing and tapping it.
5. Mix solution and additive thoroughly.
Preparation for Administration
1. Put on mask. Clean and/or disinfect hands.
2. Place EXTRANEAL on work surface.
3. Remove pull ring from connector of solution container. If continuous fluid
flow from connector is observed, discard solution container.
4. Remove tip protector from tubing set and immediately attach to connector of
solution container.
5. Continue with therapy set-up as instructed in user manual or directions
accompanying tubing sets.
6. Upon completion of therapy, discard any unused portion.
Baxter, Extraneal, UltraBag, and Ambu-Flex are trademarks of Baxter
International Inc.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
07-19-65-351
2010/10
071965351
*BAR CODE POSITION ONLY
-6-
HOW SUPPLIED
EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following
containers and fill volumes:
Container Fill Volume NDC
ULTRABAG 1.5 L NDC 0941-0679-51
ULTRABAG 2.0 L NDC 0941-0679-52
ULTRABAG 2.5 L NDC 0941-0679-53
AMBU-FLEX III 1.5 L NDC 0941-0679-45
AMBU-FLEX III 2.0 L NDC 0941-0679-47
AMBU-FLEX III 2.5 L NDC 0941-0679-48
AMBU-FLEX II 2.0 L NDC 0941-0679-06
AMBU-FLEX II 2.5 L NDC 0941-0679-05
Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte
solution with 40 mEq/L lactate.
Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See
USP Controlled Room Temperature]. Store in moisture barrier overwrap in carton
until ready to use. Protect from freezing.
Rx Only
07-19-65-351